University Of Texas MD Anderson Cancer Center: Senior Coordinator, Clinical Studies - Thoracic-Head & Neck Medical Oncology

Senior Coordinator, Clinical Studies

• Thoracic-Head & Neck Medical Oncology

JOB SPECIFIC COMPETENCIES

Protocol Management

• Independently performs protocol-specific tasks including collection of sponsor questionnaires, feasibility of screening, collecting specimens, and submission of utilization requests.

• Works with the Nurse Managers to ensure consistency between protocol database data and source documentation and OneConnect treatment plans.

• Provides open communication and continuity of operations for requesting validations for coordinator and management functions.

• Coordinates study deliverables and training between sponsor and clinical personnel.

• Provides all study related coordination necessary for submission to BEACON and Willow,

• OnCORE submission and maintenance of protocols to ensure that implementation and related clinical research activities meet specified objectives in a timely manner.

• FACT sheet completion to assists in the collection and evaluation of accurate information for feasibility of study for inpatient and CTRC infusion nurse and other personnel.

Collect procedure manuals, laboratory, and pharmacy manuals from sponsor and other written material and documentation as needed.

• Provides ideas and implements strategies for increasing enrollment on clinical trials and improving activation times for new protocols..

• Develops, recommends and implements necessary clinical study revisions for PI's approval.

• Oversees the overall effective operation of designated protocols to include development, design and resolution of operations and budget issues in collaboration with the PI or study sponsor.

Leadership & Training

• Leads clinical research study coordinator team in the management of clinical content development tools for department trials.

• Leads coordinator study meetings. Meets individually and coordinates group meetings with Principal Investigator (PI). Participates in clinical research leadership meetings.

• Trains personnel responsible for specific functions or phases within the assigned clinical research studies related to treatment plans and certificate completion of vendor access.

Protocol Auditing

• Conducts periodic in-house audits of treatment plans to ensure that the clinical research activities are in accordance with IRB protocol and/or per grant specifications.

• Participate in clinical trial activation committees for streamlining processes and improving submission and activation.

Collaborate with departmental personnel, inclusive of Finance, Regulatory, and Quality teams.

• Other duties as assigned.

Coordination of activities related to initiation and conduct of clinical trials •Develops and maintains a process and tracking system for all protocol related paperwork. Ensure research charge tickets are used appropriately.

• Communicates verbally and in writing, as needed with internal reviewers or external agencies.

• Coordinates, evaluates and follows patient progress while on studies maintaining knowledge of adverse events, protocol related labs and research tests, protocol responses. Collaborates with the multidisciplinary team as necessary to achieve the objectives of the trial.

• Collaborates with physicians, mid-level practitioners, and research nurses and data managers to assure appropriate documentation of patient care and obtain the necessary information required by the protocol.

• Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient setting. Identify and meet the educational, emotional, and psychosocial needs of patient and their families while on clinical trials.

• Coordinate, evaluate, and follow the patient's participation in clinical settings. Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of clinical trials and maintain patient safety.

• Performs protocol specific duties under direct supervision of protocol PI, research nurses manager/supervisor.

• Assist in obtaining consent for studies

• Assist in screening for adverse events

• Schedule patient tests; keep patients informed about test results and studies

• Monitor protocol compliance by assisting in coordination of protocol specific lab, radiographic, and clinical evaluation of patients

Assist in the coordination of data entry on departmental clinical research studies •Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in PDMS per protocol. Communicate necessary registration information to sponsoring Drug Company as directed by PI, and with assistance of the research nurse.

• Complete case report forms in a timely and accurate fashion. Retrieve protocol related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form.

• Develop and maintain databases for collection of research studies

• Assist in the preparation of scheduled status reports describing interim data, using CORE

• Make survival call and appropriately record the data

• Generate CORE data reports, protocol summary reports and user generated data reports as requested

• Prepare reports for the sponsoring agency, as specified by reporting requirements (e.g. monthly, semiannually, and annually for NCI studies)

Maintain a high level of professional expertise and credibility

• Attend educational programs, including on-site training and off-site conferences

• Attend departmental research meetings and conferences.

• Attend approved off-site meetings and conferences.

• Supplement education as needed through use of reference materials, lectures, etc.

• Be punctual in arriving at all professional functions.

• Inform appropriate staff and arrange coverage for necessary functions when absent

• Other duties as assigned.

Education Required

• Bachelor's degree.

Experience Required

• Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html